Impurity checks are left to the industry

Pharmacy industry settled by 2019 administration and system by the MFDS

Establishment of fast permit requirement by passing advanced bio law

As announced after the 2018 Valsartan incident, the MFDS focused on regulating generic entry this year.

 

In the sense that all restrictions can be made, irrational systems were introduced as soon as possible to prevent the entry of generics.

 

Generic regulatory measures, including restrictions on cooperative and entrusted activities, the introduction of three batches of commissioned generic trial production, and mandatory licensed generic DMF, have already been implemented or heralded.

 

Among them, the joint and consignment limit is an administrative notice announced in April, and the domestic pharmaceutical industry is under pressure and is keen to implement it.

 

Generic entry restrictions up to maximum aimed at consigned production items

The restriction on the joint and entrusted bioequivalence test was cited as the most representative generic entry regulation when criticism was raised that there were many Valsartan preparations in which carcinogen NDMA was detected.

 

Earlier this year, the MFDS held a meeting with CEOs to limit the number of items allowed for co-communication to 1 + 3 from 2020, and informed them that they will not allow it in 2022, three years later.

 

In April, the government announced an amendment to the relevant regulations and is going to start at any moment.

 

However, it is unreasonable regulation that the co-commission is not allowed.

 

In 2010, the regulatory reform committee under the Prime Minister's Office was also braked.

 

As the review of the proposed rule is delayed, it is noteworthy whether the 1+3 regulation, which was announced in the first half of next year, will be implemented on time.

 

Currently, generic drugs of the same ingredient produced in the same plant through a consignment contract are replaced by a review of the existing Bioequivalence test by existing consignees.

 

This has been criticized for the exponential increase in the number of generically approved generic ingredients.

 

In November, it announced the introduction of another regulation.

 

The contractor is obligated to produce three batches of licensed drugs that were exempted.

 

The system, which disappeared in 2014, has also been revived in the name of preventing generic upheaval.

 

Once this system is introduced, the consignor, who is entrusted with the production of the consignment company, must test and produce three batches as part of the GMP review, even at the time of generic approval.

 

The domestic pharmaceutical industry is complaining of the burden of livestock costs due to the limitation of co-prosperity and the additional cost of trial production due to the revitalization of three batches.

 

There are also new regulations that have already been announced as part of the ban on generics.

 

In March, an amendment that mandates the submission of safety proof data on the genotoxicity or carcinogenic impurities and metal impurities of medicines will be announced in next September.

 

In October, an amendment was announced to include licensed generics in stages for drug substance registration.

 

▲ Commercial drugs by December 31, 2021 ▲ High-cost drugs by December 31, 2022 ▲ Other drugs and drugs that require testing without a living body should register DMF by June 30, 2023.

 

Since June 12, the pharmacological law revision has extended the restriction period for healthy people to participate in clinical trials to six months, making it difficult to conduct bioequivalence trials in the field.

 

Ranitidine, Nizatidine Impurities Continue to Burst, direct assessment of all synthetic raw materials Even during the mobilization of generic regulations, the fear of impurities in pharmaceuticals did not go away.

 

Following the hypertension Valsartan formulation, the carcinogen NDMA was continuously detected in the gastric ulcer therapeutic Ranitidine and Nizatidine formulations.

 

Pharmaceutical industry officials attending the drug impurity response briefing held at Samjung Hotel on the 6th attended and showed interest.

The MFDS banned sales and recovery of all Ranitidine products in September, and banned and recalled some Nizatidine products in November.

 

In addition, as NDMA is detected in the anti-diabetic Metformin preparation in Singapore, some items are being recovered and impurity fears are still in shape.

 

The MFDS instructed pharmaceutical companies to submit their own results of impurity evaluations to all synthetic materials by next May and test results on drugs concerned with impurities by May 2021 for self-examination of persistent impurity issues.

 

Advanced Law Passes Parliament, laying grounds for fast track such as serious diseases Unlike generic regulation, new types of drugs have provided the basis for supporting rapid licensing.

 

This is accelerated in August when the Act on Advanced Renewable Medical and Advanced Biologics Safety and Support passed the National Assembly.

 

As a result, drugs that need to come to market early, such as serious illnesses, rare diseases, and pandemic infections, will be included in the expedited treatment for early approval.

 

The organization and system are being set up by establishing the Convergence Innovative Product Support Group in the Korea Food and Drug Administration for the next August.

 

However, the threshold for safety testing for advanced drugs has been strengthened due to the effects of ' Invossa', which was released in April due to the fact that the main component cells were changed and the license was revoked.